Category Archives: Events

01Feb/17
FDA_small

Hear Directly from FDA: Driving a Culture of Quality for Devicemakers

Webinar Announcement

FDA and Industry Find Common Ground Driving a Culture of Quality

DATE: March 1, 2017
TIME: 1:30PM Eastern

Industry leaders and regulators are working on the Case for Quality (CfQ) initiative to shift their focus from compliance to quality by giving greater focus and emphasis to critical-to-quality practices throughout the lifecycle of the product.

Would you like to reduce your regulatory burden? Pay dividends in enhanced and predictable product performance? Streamline processes resulting in operational efficiencies? Reduce waste driving to lower costs and improved profitability?

CFQ_Webinar1

Join Sean Boyd — Deputy Director for Regulatory Affairs, CDRH’s Office of Compliance — Francisco (Cisco) Vicenty — Program Manager (Acting), Case for Quality, FDA — and Daniel R. Matlis — President, Axendia — on March 1st when they’ll discuss the effect the CfQ will have on med-tech manufacturers, healthcare providers, regulators and ultimately the patient.

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12Dec/16
veeva-logo

Unifying Applications to Drive Effectiveness, Efficiency and Compliant Collaboration

By: Sandra K. Rodriguez, Market Analyst

Using a Cloud Platform to Connect the Life Science Value Chain

Pharmaceutical, Bio-Tech and Medical Device companies are increasingly adopting cloud platforms to drive effectiveness and efficiency throughout the value chain.  These organizations are unifying applications that support the total product lifecycle in a compliant manner, without losing sight of what matters most – product quality.

This shift from disconnected point solutions to a platform approach became clear at the Veeva Systems Global Summit for Clinical, Regulatory, and Quality in Philadelphia on October 17-19, 2016, where I joined over 600 attendees representing 154 companies.  Client presentations ranged from start-up to multi-national Life-Science companies including Regeneron, Shire and Johnson & Johnson. A list of presenters can be found here.

Jennifer Goldsmith, Senior Vice President, Veeva Vault

Jennifer Goldsmith, Senior Vice President, Veeva Vault

Jennifer Goldsmith, Senior Vice President, Veeva Vault kicked off the event by celebrating the five-year birthday of Vault.  This was my first time covering the event and I was immediately surprised by the opening keynote delivered by Peter Gassner, CEO at Veeva Systems.  He revealed that over the past three years, the company has consistently doubled its customer base across all three of its product offerings – Vault Clinical, Vault Quality and Vault Regulatory.  Sessions were offered across all three areas including a track on platforms and a focus on small and mid-size organizations. Continue reading

29Sep/16
gudid

Hear Directly from FDA: Are You Done with UDI or Is This Just the Beginning?

Webinar Announcement 

Are you done with UDI… or is it just the beginning?  Hear directly from FDA’s Senior Advisor for UDI and Industry Experts the profound effect UDI implementation will have on Med-Tech manufacturers, healthcare providers, regulators and ultimately the patient.

On Oct. 13th at 1:30pm Eastern, join Terrie Reed, Senior Advisor for UDI Adoption at the FDADaniel R. Matlis of Axendia, and Jean Colombel of Dassault Systemes as they discuss UDI and how its value resides in the ability to optimize meaningful data collection and analysis.

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23Aug/16
Thingworx-solutions-for-medical-devices

Is IoT Vital to Well-Care?

By: Daniel R. Matlis, President

Improving Healthcare in the Outcome Economy

The Internet of Things (IoT) and the transition to the Outcome Economy were key themes at PTC’s LiveWorx16.  The focus on IoT and Product Lifecycle Management (PLM) and the shift to outcome based models, sparked this analysis on the applicability of these trends in our “sick-care system.”

The traditional healthcare model could better be described as “sick-care.”  Historically, healthcare has been episodic and reactive — primarily aimed at addressing a malady, illness or injury after it has already happened.

Here are a few examples:

  • Have a fever?                    →          Take an antipyretic.
  • Have an ache?                           Take an analgesic.
  • Have a damaged hip?                Have an arthroplasty.
  • Have angina?                              Have coronary artery bypass graft surgery.

This sick-care approach has it backwards, though. As the refrain goes, an ounce of prevention is worth a pound of cure. Furthermore, sick-care is expensive and unsustainable.  But, can we apply the IoT, PLM, and outcome-based models to healthcare? Continue reading